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Direclidine, also known by its development code NBI-1117568, is a chemically synthesised substance that is being investigated as a potential treatment for schizophrenia. It is being developed by Neurocrine Biosciences Inc.[1][2] The substance is classified in the therapeutic area of psychiatry and psychology, specifically for mental disorders.[1] Direclidine is an investigational substance, which means it has not yet received a marketing authorisation and is not available as a prescribed medicine.[1]
The available registry records and supplementary sources do not provide a detailed description of the mechanism of action of direclidine. The clinical trial programme is designed to evaluate whether direclidine can improve the behavioural and psychological symptoms of schizophrenia, but the specific molecular target or biological pathway through which it may act is not described in the provided data.[1]
Direclidine is given as a hard capsule that is taken by mouth (oral use). The product records from the clinical trials list the pharmaceutical form as a hard capsule and the route of administration as oral.[1] In the registered trials, the dose amounts are not reported in the registry records (listed as 00 mg).[1][2]
There are two Phase 3 clinical trials registered for direclidine in adults with schizophrenia. Both trials are authorised, meaning they have received regulatory approval to proceed, and one is described in a supplementary source as currently recruiting.[1][2][3]
The first trial measures the change from baseline in the PANSS total score at Week 5. The PANSS (Positive and Negative Syndrome Scale) is a standard scale used to assess the severity of symptoms in schizophrenia, including positive symptoms such as hallucinations and delusions, negative symptoms such as social withdrawal, and general psychopathology.[1] The second trial measures the occurrence of adverse events (AEs) during an open-label treatment period, with the aim of evaluating the long-term safety and tolerability of direclidine.[2]
The trials are open to adults with schizophrenia. The first trial specifically includes adults with schizophrenia who warrant inpatient hospitalisation, meaning they require treatment in a hospital setting.[1] The second trial is open to adults with schizophrenia more broadly.[2] The first trial is a randomised, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either direclidine or a placebo, and neither the participants nor the researchers know which treatment is being given.[3]
The first trial has a planned enrolment of 284 participants, and the second trial has a planned enrolment of 699 participants.[1][2]
The available supplementary sources do not provide a list of side effects for direclidine. The long-term safety trial is specifically designed to collect information on the occurrence of adverse events during treatment, which will help to establish the side effect profile of the medicine.[2]
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